Could a Pig's Sexual Maturity Hold a Key to Reversing Diabetes?

By co-transplanting Sertoli cells together with insulin-producing cells

into diabetic rats, his recent research demonstrated that

insulin-producing cells can survive and can protect the rats against diabetes. By

substituting the Sertoli cells from adult pigs, instead of those from

baby pigs, Dr. White may have made a medical research breakthrough.



StockInterview: How long have you been involved in researching the

reversal of diabetes?



Dr. David White: I first started my interest in treating diabetes by

transplantation of insulin cells when I was on faculty at the University

of Cambridge in the United Kingdom. That would have been about 1996. I

guess I've been doing this now for over 10 years.



StockInterview: Please tell us about xenotransplantation and why this

could play an important role in reversing diabetes.



Dr. David White: The issue with using xenotransplantation is

essentially one of numbers. There has been some excellent work done in Edmonton

(Canada) that shows that human-to-human transplants of insulin-producing

cells can reverse diabetes. The problem is that you need human donors

to produce the insulin producing cells, and they're in short supply.

The Edmonton (Protocol) is treating perhaps twenty patients each year.

If you look at the numbers, there are about 80,000 diabetics per million

of population. Of those, perhaps ten percent are called type I

diabetics who would most benefit from our therapy - 8,000 per million of

population. If you look at the availability of human donors in Canada,

you're talking 15 per million. So, what happens to the other 7,985

patients? If you do xenotransplantation, animal-to-human transplants, we use

pigs. There is no shortage of pigs. We can have thousands and thousands

of them. That's the big benefit of our technology. It's a therapy

instead of just pushing at the edges.





StockInterview: On February 5th, Sernova Corp announced the results of

your recent diabetes research. The headline stated 'Insulin-Producing

Cells Could Survive and Function without Anti-Rejection Drugs.' Why

is that an important milestone in helping to find a way to reverse

diabetes?



Dr. David White: The important thing about Sernova's technology is

that we use a very specific cell called the Sertoli cell. What this

Sertoli cell does is: it confers immune privilege. Now the big breakthrough

that we made was to discover that if you use Sertoli cells from adult

pigs as opposed to what everybody else in the field has been doing -

using it from sexually immature baby pigs, we get very much greater

protection. In fact, we can completely suppress the immune response to pig

insulin-producing cells with these adult Sertoli cells. What we've

been able to do, is to co-transplant Sertoli cells and insulin-producing

cells into diabetic rats, show these insulin-producing cells will

survive, and will protect the rats against diabetes. We think that's a

pretty exciting step forward.





StockInterview: We are assuming Sernova Corp's patented

insulin-producing cellular replacement therapy, called Sertolin, is how the company

plans to commercialize your ongoing research to help reverse diabetes.

How quickly are you moving toward this goal? And what steps must you

take before it could become commercially available?



Dr. David White: I think it's important that people realize how both

the pharmaceutical industry and the biotech industry work. First of

all, we're regulated by the FDA. To some extent, it's the FDA that

will determine both the steps we must take and the timelines. Let me give

you a simple example. Many years ago, I was involved in the development

of the drug called Cyclosporin-A which is used to prevent transplants

rejecting. The big breakthrough that we discovered was in 1977. That

drug came on the market in 1984, a seven year time span. Now we made our

basic big discovery on Sernova's technology in 2005, so (we are) three

years in. On that basis, we probably got another four years to go on

commercialization. Hopefully we can cut that time down, because we

already have a significant amount of clinical data. We will certainly be

asked by the FDA to go into Phase II trial. But they may ask for a trial

lasting one year, they may ask for a trial lasting two years. That

extent, the timeline is out of our hands. Clearly, we are pushing ahead as

fast as possible. Our next step is to gather all the data needed by the

FDA to apply for an IND (Investigational New Drug). That is permission

to start a clinical trial in regulated countries. That would be the

United States and Canada.



StockInterview: Upon which model are you basing your research? What are

the strengths and deficiencies in this model?



Dr. David White: There are no good experimental, pre-clinical models of

diabetes. The best model is the human diabetic. The model we currently

use, is to transplant pig cells into diabetic rats, but we make the

rats diabetic by poisoning the insulin-producing cells they would

otherwise have. Then, when they're rendered diabetic, we cure them with the

Sertolin product. It's not a great model, but it's the best model we

have.



StockInterview: Your company has assembled quite a prestigious

Scientific Advisory Board. How did your peer group react to the results of your

recent research? What advice did they offer?



Dr. David White: We do have an excellent Scientific Advisory Board made

up of some of the best experts in North America in the field. We

presented our data to them a couple of weeks ago, and they got very excited.

The basic advice they offered was to say: Do more pre-clinical studies,

beef up your numbers, show how producible your technology is, and deal

with the technological issues like defining the purity of the product,

the best ways to prepare it, how to scale up for commercialization. All

in all, it was a very exciting meeting. We're very encouraged by

their enthusiasm and their acknowledgement of the progress that we've

made.



StockInterview: What else should investors know about Sernova Corp and

the research you are currently doing?



Dr. David White: I think the important message is that our goal is to

get to clinical trial as rapidly as possible and our target is to be

discussing those possibilities with the FDA by the end of this year.





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James Finch contributes to StockInterview.com and other publications.

His focus on the uranium mining and nuclear fuel sector resulted in the

widely popular "Investing in the Great Uranium Bull Market," which

is now available on http://www.stockinterview.com and on

http://www.amazon.com